KFM — Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class II
FDA product code KFM covers "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type", a Class II medical device regulated under 21 CFR 870.4360. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KFM
- Device Class
- Class II
- Regulation Number
- 870.4360
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251762 | spectrum medical | Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-N | August 4, 2025 |
| K250326 | spectrum medical | Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-N | June 24, 2025 |
| K233091 | qura | Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) | October 26, 2023 |
| K232132 | cardiacassist | LifeSPARC System | August 3, 2023 |
| K220842 | qura | Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum P | May 19, 2023 |
| K200091 | terumo cardiovascular systems corporation | Capiox iCP Centrifugal Pump | November 18, 2021 |
| K201320 | qura | Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor | November 3, 2021 |
| K193663 | international biophysics corporation | FloPump 57mL Centrifugal Pump | March 10, 2021 |
| K202169 | qura | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood | September 2, 2020 |
| K201068 | medtronic | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Bala | May 21, 2020 |
| K192850 | qura | Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood | April 13, 2020 |
| K191077 | medtronic | Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Bala | August 27, 2019 |
| K190650 | sorin group italia | Revolution Centrifugal Blood Pump | August 7, 2019 |
| K183623 | cardiacassist | LifeSPARC Pump, LifeSPARC Controller | July 9, 2019 |
| K170029 | international biophysics corporation | FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile | December 15, 2017 |
| K132712 | medtronic | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER | November 19, 2013 |
| K133265 | maquet cardiopulmonary | QUADROX-IR ADULT AND SMALL ADULT | November 12, 2013 |
| K112229 | terumo cardiovascular systems | SARN CENTRIFUGAL PUMP | December 9, 2011 |
| K110493 | cardiacassist | TANDEMHEART PUMP | September 20, 2011 |
| K111972 | medtronic | AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AF | July 27, 2011 |